FDA.report

PowerGroshong Catheter

Primary DI
10801741028523
Brand
PowerGroshong Catheter
Company
Bard Access Systems, Inc.
Model
7818508
Catalog number
7818508
Device description
DOT PowerGRO, 5Fr SL,
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
LJSCatheter,intravascular,therapeutic,long-term greater than 30 days

Product Code Classifications

CodeDeviceSpecialtyClass
LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 DaysGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10801741028523PackageGS15In Commercial Distribution
00801741028526PrimaryGS10

GMDN Terms

TermDefinition
Peripherally-inserted central venous catheterA sterile, thin, flexible tube intended to be introduced into a peripheral vein and advanced to a central vein for short- to long-term intravascular access to administer medications (antibiotics), chemotherapeutic agents, nutrients, parenteral solutions, pain management fluids, and sometimes for blood sampling, monitoring of blood pressure and temperature, and for power injection of contrast media; it is not primarily intended for extracorporeal blood therapies such as haemodialysis. Also known as a peripherally inserted central catheter (PICC), it typically includes dedicated accessories to facilitate catheter introduction/function (e.g., Luer hubs, stylet). This is a single-use device.

Device Sizes

TypeValueUnit
Catheter Gauge5French
Length45Centimeter

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)545-0890medical.services@crbard.com

Regulatory Flags

DUNS number
044611812
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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10801741231282CentroVena One1K0R72201K0R72202026-01-23
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10801741231312CentroVena One1K0R73201K0R73202026-01-23
10801741231329CentroVena One1K0R73301K0R73302026-01-23
10801741231336CentroVena One1MB0R72161MB0R72162026-01-23
10801741231343CentroVena One1MB0R72201MB0R72202026-01-23
10801741231350CentroVena One1MB0R73161MB0R73162026-01-23
10801741231367CentroVena One1MB0R73201MB0R73202026-01-23
10801741231374CentroVena One1MB0R73301MB0R73302026-01-23

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